Galantamine extended-release capsules

Pronunciation

Generic Name: galantamine (ga-LAN-ta-meen)
Brand Name: Razadyne ER

Galantamine extended-release capsules is used for:

Treating mild to moderate dementia (eg, impairment of memory or judgment, abstract thinking, changes in personality) in patients with Alzheimer disease.

Galantamine extended-release capsules is a cholinesterase inhibitor. It works by increasing the amount of a certain substance (acetylcholine) in the brain, which may help reduce symptoms of dementia in patients with Alzheimer disease.

Do NOT use galantamine extended-release capsules if:

  • you are allergic to any ingredient in galantamine extended-release capsules
  • you have severe liver or kidney problems

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using galantamine extended-release capsules:

Some medical conditions may interact with galantamine extended-release capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver or kidney problems, heart problems (eg, slow or irregular heartbeat, sick sinus syndrome), unexplained fainting episodes, stomach or bowel problems (eg, ulcer, blockage), lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD]), urinary blockage or trouble urinating, or seizures (eg, epilepsy)
  • if you have dementia or other decreased mental ability that is not caused by Alzheimer disease
  • if you will be having surgery or will be receiving anesthesia
  • if you take any medicine that may slow your heartbeat (eg, digoxin, diltiazem, verapamil). Check with your doctor or pharmacist if you are unsure if any of your medicines may slow your heartbeat

Some MEDICINES MAY INTERACT with galantamine extended-release capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of stomach or bowel bleeding may be increased
  • Cholinergic agents (eg, bethanechol), cholinesterase inhibitors (eg, donepezil), ketoconazole, or selective serotonin reuptake inhibitors (SSRIs) (eg, paroxetine) because they may increase the risk of galantamine extended-release capsules's side effects
  • Anticholinergics (eg, scopolamine) because their effectiveness may be decreased by galantamine extended-release capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if galantamine extended-release capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use galantamine extended-release capsules:

Use galantamine extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take galantamine extended-release capsules by mouth in the morning, unless your doctor tells you otherwise. You may take it with or without food, but taking it with food is recommended.
  • Swallow galantamine extended-release capsules whole. Do not break, crush, or chew before swallowing.
  • Drinking extra fluids while you are taking galantamine extended-release capsules is recommended. Check with your doctor for instructions.
  • Take galantamine extended-release capsules on a regular schedule to get the most benefit from it.
  • Taking galantamine extended-release capsules at the same time each day will help you remember to take it.
  • Continue to take galantamine extended-release capsules even if you feel well. Do not miss any doses.
  • If you miss a dose of galantamine extended-release capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Contact your doctor if you miss several doses of galantamine extended-release capsules. Your doctor may need to restart your medicine at a lower dose to avoid side effects.

Ask your health care provider any questions you may have about how to use galantamine extended-release capsules.

Important safety information:

  • Galantamine extended-release capsules may cause dizziness, drowsiness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use galantamine extended-release capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not take more than the recommended dose without checking with your doctor.
  • When you begin taking galantamine extended-release capsules, your doctor will increase your dose slowly over several months. This may help to decrease the risk of certain side effects (eg, nausea, vomiting, diarrhea). Carefully follow the dosing schedule prescribed by your doctor.
  • Tell your doctor or dentist that you take galantamine extended-release capsules before you receive any medical or dental care, emergency care, or surgery.
  • Use galantamine extended-release capsules with caution in the ELDERLY; they may be more sensitive to its effects.
  • Galantamine extended-release capsules should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using galantamine extended-release capsules while you are pregnant. It is not known if galantamine extended-release capsules is found in breast milk. If you are or will be breast-feeding while you use galantamine extended-release capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of galantamine extended-release capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; indigestion; loss of appetite; mild stomach pain or upset; nausea; tiredness; trouble sleeping; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; burning, numbness, or tingling; chest pain; confusion; decreased, difficult, or painful urination; fainting; fever; hallucinations; mental or mood changes (eg, anxiety, depression); new or worsening breathing problems (eg, shortness of breath); one-sided weakness; seizures; severe or persistent diarrhea, nausea, stomach pain, or vomiting; severe or persistent dizziness, tiredness, or weakness; slow or irregular heartbeat; speech problems; swelling of the hands, ankles, or feet; tremor; vision problems; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; increased sweating, or tear or saliva production; loss of bowel control; loss of consciousness; muscle weakness; seizures; severe dizziness; severe nausea or vomiting; slow or irregular heartbeat; slow or shallow breathing; stomach cramping.

Proper storage of galantamine extended-release capsules:

Store galantamine extended-release capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep galantamine extended-release capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about galantamine extended-release capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Galantamine extended-release capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take galantamine extended-release capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about galantamine extended-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to galantamine extended-release capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using galantamine extended-release capsules.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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